Powered Exoskeleton for the Treatment of Elbow Spasticity

Stroke Clinical Trial

Official title:

Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity: Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02934646
• Other study ID #: RN20161
• Status: Completed
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2018
• Source: Auxilium Vitae Volterra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase-II clinical study to assess whether intense passive mobilization of the elbow during the early stage is effective in preventing spasticity from occurring at a later stage. A group of subacute stroke patients was treated with the device named NEUROExos Elbow Module (NEEM) on a daily basis, in addition to traditional physical therapy. The outcome was assessed in terms of (i) system safety, (ii) system usability and (iii) treatment efficacy.

Investigators expected that intense therapy performed in the sub-acute phase following the stroke would be effective in preventing elbow spasticity from occurring at a later stage (i.e. 3-4 months after the stroke), the latter being quantified by means of the Modified Ashworth Scale (MAS). Similarly to other phase-II studies in the field of post-stroke rehabilitation, the present study will include only one group of patients. As a secondary objective, similarly to other studies with robot-assisted therapy, investigators wiil test the ability of this system to be used for assessing rehabilitation outcome. Investigators will introduce novel evaluation metrics based on the kinematics and kinetics variables recorded by the NEEM and compared them with MAS values.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Upper limb spasticity due to neurological impairment;

2. Cognitive abilities sufficient for understanding instructions;

3. Absence of severe pain assessed as Visual Analogic Score (VAS) < 4 (range 0-10).

Exclusion Criteria:

1. Unstable general clinical conditions;

2. Unability to keep sitting posture;

3. Tendon retractions limiting upper limb joints range of motion.

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

Device:
• Robotic treatment
Passive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Auxilium Vitae Volterra	Azienda USL Toscana Nord Ovest, Scuola Superiore Sant'Anna di Pisa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth Scale	Impairmente level maesure according to ICF	2 weeks
Secondary	Range of Motion	Impairmente level maesure according to ICF	2 weeks
Secondary	Maximum Extension Torque	Paramenter directly exterted by the device	2 weeks
Secondary	Zero-Torque Angle	Paramenter directly exterted by the device	2 weeks